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Efficiency of an Optimized Care Organization for Fibromyalgia Patients. The FIMOUV 2 Study (FIMOUV 2)

Primary Purpose

Fibromyalgia, Physical Activity

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

physical activity program

Advice and recommendations of physical activity at home

About this trial

This is an interventional other trial for Fibromyalgia focused on measuring sedentary time, therapeutic education sessions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient diagnosed with fibromyalgia according to ACR (American College of rheumatology) criteria (total score WPI (Widespread Pain Index) + SS (Severity Scale) ) ≥ 13
French writing and speaking
Sedentary or low level of activity (less than 150 minutes of regular physical activity per week at the time of inclusion)
Signature of informed consent

Exclusion Criteria:

Cardiac or respiratory diseases that contraindicate the practice of physical activity
Significant co-morbidities that contraindicate the practice of physical activity: associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies (severe obstructive or severe respiratory insufficiency), disabling joint pathologies (knee osteoarthritis or osteoarthritis of the hip) training on a treadmill or on a high intensity bike).
Impossibility of submitting to the medical monitoring of the program for geographical, social or psychological reason

Sites / Locations

CH d'ANNONAYRecruiting
CH de FirminyRecruiting
CH de MONTBRISONRecruiting
CH de Rive de Gier
CH de ROANNERecruiting
CH du GierRecruiting
Chu Saint EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

fibromyalgia patients with physical activity program

fibromyalgia patients with physical activity at home

Arm Description

Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified "Sports Health" in the Loire (42) or Haute-Loire (43) for 2 months.

Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).

Outcomes

Primary Outcome Measures

physical activity

Measure the durability of adherence/therapeutic compliance of fibromyalgia patients based on an objective measurement of physical activity: average measured from 7 days of actimetry, Actigraph

Secondary Outcome Measures

sedentary

Measure the durability of adhesion/therapeutic compliance of fibromyalgia patients based on an objective measurement of sedentary : average measured from 7 days of actimetry, Actigraph

physical activity

Objective and repeated measurement of physical activity over 7 days using actimetry, Actigraph

sedentary

Objective and repeated measurement of sedentary over 7 days using actimetry, Actigraph

health status

measured with Patient Global Impression of Change (PGIC) : on a 7-point scale, rated from 1 for "much worse" to 7 for "much better". It is a simple and practical evaluation tool to use. The combination of the level of achievement via the Patient Global Impression of Change and the initial documentation of the patient's objectives via the shared educational assessment is a relevant and understandable approach for the patient.

fatigue

assessed by Fatigue Severity Scale. This is a short questionnaire of 9 questions to which the patient answers on a scale from 1 to 7. Simply add the scores and divide by 9 - you get a result on 7 points. The higher the result, the greater the fatigue. Several studies speak of a threshold at 5.5

Quality of sleep

assessed by the Pittsburgh. The questionnaire includes 19 self-assessment questions and 5 questions for the spouse or roommate (if any). Only self-assessment questions are included in the score. The 19 self-assessment questions combine to give 7 components" of the score with each component receiving a score of 0 to 3. In all cases, a score of 0 indicates that there is no difficulty while a score of 3 indicates the existence of severe difficulties. The 7 components of the score add up to give an overall score from 0 to 21 points, 0 meaning that there is no difficulty, and 21 indicating on the contrary major difficulties.

Anxiety and Depression

assessed by the Hospital Anxiety and Depression Scale (HADS) : An overall score of 19 or more indicates a major depressive episode. An overall score of 13 corresponds to adjustment disorders and minor depression.

pain catastrophizing

assessed by the PCS (pain catastrophizing scale) assessing catastrophism : there are thirteen statements describing different thoughts and emotions that may be associated with pain. the person must indicate how painful these thoughts and emotions are. From 0= not at all to 4 = all the time

pain evaluation

assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)

fatigue evaluation

assessed by analog visual evaluation of fatigue (0= no fatigue and 10 = maximum fatigue)

muscle power

evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.

muscular endurance

evaluated by dynamometry on a stress platform (arms and legs).

gas exchange measurement

evaluated during a stress test

fatigue

evaluated with Baroreflex Sensitivity. measurement of the slope of the baroreflex

quantification of physical activity in meter-h/week

evaluated by the APAQ : Adult Physical Activity Questionnaire

sedentary times in hours/day

evaluated by the APAQ : Adult Physical Activity Questionnaire

patient adherence

number of sessions performed

Direct medical costs

consultations, examinations, hospitalizations in euros

Direct non-medical costs

transport

Cost of lost productivity

time not worked

Full Information

NCT ID

NCT04107948

First Posted

September 26, 2019

Last Updated

June 13, 2023

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

1. Study Identification

Unique Protocol Identification Number

NCT04107948

Brief Title

Efficiency of an Optimized Care Organization for Fibromyalgia Patients. The FIMOUV 2 Study

Acronym

FIMOUV 2

Official Title

Efficiency of an Optimized Care Organization for Fibromyalgia Patients Within the Group of Hospitals of Loire Territory. Interventional Study Aimed at Changing Behaviour in Terms of Physical Activity and Sedentary

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 23, 2020 (Actual)

Primary Completion Date

October 1, 2024 (Anticipated)

Study Completion Date

October 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest. The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest. Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.

Detailed Description

In order to set up an optimal patient path within the Group of hospitals of Loire territory, the working group composed of doctors from different specialities of the department considered it important to carry out a randomised study evaluating the effectiveness of a healthcare organisation combining: an adapted and supervised physical activity intervention (1 month hospital initiation then 2 months in town) therapeutic education sessions for the patient with motivational interviews Compared to usual clinical practice (adapted physical activity adapted in autonomy at home + therapeutic patient education sessions with motivational interviews).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia, Physical Activity

Keywords

sedentary time, therapeutic education sessions

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

fibromyalgia patients with physical activity program

Arm Type

Experimental

Arm Description

Arm Title

fibromyalgia patients with physical activity at home

Arm Type

Other

Arm Description

Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).

Intervention Type

Other

Intervention Name(s)

physical activity program

Intervention Description

Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified "Sports Health" in the Loire (42), Haute-Loire (43) or Ardèche (07) for 2 months.

Intervention Type

Other

Intervention Name(s)

Advice and recommendations of physical activity at home

Intervention Description

Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).

Primary Outcome Measure Information:

Title

physical activity

Description

Measure the durability of adherence/therapeutic compliance of fibromyalgia patients based on an objective measurement of physical activity: average measured from 7 days of actimetry, Actigraph

Time Frame

12 months

Secondary Outcome Measure Information:

Title

sedentary

Description

Measure the durability of adhesion/therapeutic compliance of fibromyalgia patients based on an objective measurement of sedentary : average measured from 7 days of actimetry, Actigraph

Time Frame

12 and 24 months

Title

physical activity

Description

Objective and repeated measurement of physical activity over 7 days using actimetry, Actigraph

Time Frame

0, 1, 3, 6, 12 and 24 months

Title

sedentary

Description

Objective and repeated measurement of sedentary over 7 days using actimetry, Actigraph

Time Frame

0, 1, 3, 6, 12 and 24 months

Title

health status

Description

Time Frame

0, 1, 3, 6, 12 and 24 months

Title

fatigue

Description

Time Frame

0, 1, 3, 6, 12 and 24 months

Title

Quality of sleep

Description

Time Frame

0, 1, 3, 6, 12 and 24 months

Title

Anxiety and Depression

Description

Time Frame

0, 1, 3, 6, 12 and 24 months

Title

pain catastrophizing

Description

Time Frame

0, 1, 3, 6, 12 and 24 months

Title

pain evaluation

Description

assessed by analog visual evaluation of pain (0= no pain and 10 = very painful)

Time Frame

6 and 12 months

Title

fatigue evaluation

Description

assessed by analog visual evaluation of fatigue (0= no fatigue and 10 = maximum fatigue)

Time Frame

6 and 12 months

Title

muscle power

Description

evaluated by dynamometry on a stress platform (arms and legs) and by a pocket dynamometer.

Time Frame

0, 1 and 3 months

Title

muscular endurance

Description

evaluated by dynamometry on a stress platform (arms and legs).

Time Frame

0, 1 and 3 months

Title

gas exchange measurement

Description

evaluated during a stress test

Time Frame

0, 1 and 3 months

Title

fatigue

Description

evaluated with Baroreflex Sensitivity. measurement of the slope of the baroreflex

Time Frame

0, 1 and 3 months

Title

quantification of physical activity in meter-h/week

Description

evaluated by the APAQ : Adult Physical Activity Questionnaire

Time Frame

0, 1, 3, 6,12 and 24 months

Title

sedentary times in hours/day

Description

evaluated by the APAQ : Adult Physical Activity Questionnaire

Time Frame

0, 1, 3, 6, 12 and 24 months

Title

patient adherence

Description

number of sessions performed

Time Frame

6 and 12 months

Title

Direct medical costs

Description

consultations, examinations, hospitalizations in euros

Time Frame

12 months

Title

Direct non-medical costs

Description

transport

Time Frame

12 and 24 months

Title

Cost of lost productivity

Description

time not worked

Time Frame

12 and 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient diagnosed with fibromyalgia according to ACR (American College of rheumatology) criteria (total score WPI (Widespread Pain Index) + SS (Severity Scale) ) ≥ 13 French writing and speaking Sedentary or low level of activity (less than 150 minutes of regular physical activity per week at the time of inclusion) Signature of informed consent Exclusion Criteria: Cardiac or respiratory diseases that contraindicate the practice of physical activity Significant co-morbidities that contraindicate the practice of physical activity: associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies (severe obstructive or severe respiratory insufficiency), disabling joint pathologies (knee osteoarthritis or osteoarthritis of the hip) training on a treadmill or on a high intensity bike). Impossibility of submitting to the medical monitoring of the program for geographical, social or psychological reason

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David HUPIN

Phone

0477828413

Ext

+33

David.Hupin@chu-st-etienne.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Marie PEURIERE

Phone

0477829272

Ext

+33

marie.peuriere@chu-st-etienne.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David HUPIN

Organizational Affiliation

CHU de Saint Etienne

Official's Role

Principal Investigator

Facility Information:

Facility Name

CH d'ANNONAY

City

Annonay

ZIP/Postal Code

07100

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mariana PERNEA, MD

Facility Name

CH de Firminy

City

Firminy

ZIP/Postal Code

42700

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aurélie ROBLES, MD

Facility Name

CH de MONTBRISON

City

Montbrison

ZIP/Postal Code

42600

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean Paul CHAUSSINAND, MD

Facility Name

CH de Rive de Gier

City

Rive-de-Gier

ZIP/Postal Code

42800

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bachir SAHI, MD

First Name & Middle Initial & Last Name & Degree

Marceline SIX, MD

Facility Name

CH de ROANNE

City

Roanne

ZIP/Postal Code

42300

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Delphine VERGNON MISZCZYCHA, MD

First Name & Middle Initial & Last Name & Degree

Mervyn MUNGROO, MD

Facility Name

CH du Gier

City

Saint Chamond

ZIP/Postal Code

42400

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maxime Bataillard, MD

Facility Name

Chu Saint Etienne

City

Saint Etienne

ZIP/Postal Code

42055

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

HUPIN David

David.Hupin@chu-st-etienne.fr

First Name & Middle Initial & Last Name & Degree

FEASSON Léonard, MD

First Name & Middle Initial & Last Name & Degree

ROCHE Frédéric, MD

First Name & Middle Initial & Last Name & Degree

CALMELS Paul, MD

First Name & Middle Initial & Last Name & Degree

CREAC'H Christelle, MD

First Name & Middle Initial & Last Name & Degree

CATHEBRAS Pascal, MD

First Name & Middle Initial & Last Name & Degree

FAYOLLE-MINON Isabelle, MD

First Name & Middle Initial & Last Name & Degree

LUCHT Frédéric, MD

First Name & Middle Initial & Last Name & Degree

THOMAS Thierry, MD

First Name & Middle Initial & Last Name & Degree

MAROTTE Hubert, MD

First Name & Middle Initial & Last Name & Degree

CAMDESSANCHE Jean Philippe, MD

First Name & Middle Initial & Last Name & Degree

MASSOUBRE Catherine, MD

First Name & Middle Initial & Last Name & Degree

FONTANA Luc, MD

First Name & Middle Initial & Last Name & Degree

LIETAR Béatrice, MD

First Name & Middle Initial & Last Name & Degree

NAVEZ Malou, MD

First Name & Middle Initial & Last Name & Degree

NAYME Philippe, MD

First Name & Middle Initial & Last Name & Degree

GOUTTE Julie, MD

First Name & Middle Initial & Last Name & Degree

KILLIAN Martin, MD

First Name & Middle Initial & Last Name & Degree

Clément FOSCHIA, MD

First Name & Middle Initial & Last Name & Degree

Marine SORG, MD

First Name & Middle Initial & Last Name & Degree

Claire COLAS, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34354626

Citation

Colas C, Jumel A, Vericel MP, Barth N, Manzanares J, Goutte J, Fontana L, Feasson L, Hupin D, Guyot J. Understanding Experiences of Fibromyalgia Patients Involved in the Fimouv Study During COVID-19 Lockdown. Front Psychol. 2021 Jul 20;12:645092. doi: 10.3389/fpsyg.2021.645092. eCollection 2021.

Results Reference

derived

PubMed Identifier

34113593

Citation

Colas C, Goutte J, Creac'h C, Fontana L, Vericel MP, Manzanares J, Peuriere M, Akrour M, Martin C, Presles E, Barth N, Guyot J, Garros M, Trombert B, Massoubre C, Roche F, Feasson L, Marotte H, Cathebras P, Hupin D. Efficiency of an Optimized Care Organization in Fibromyalgia Patients: The From Intent to Move (FIMOUV) Study Protocol of a Randomized Controlled Trial. Front Public Health. 2021 May 25;9:554291. doi: 10.3389/fpubh.2021.554291. eCollection 2021.

Results Reference

derived

Learn more about this trial

Efficiency of an Optimized Care Organization for Fibromyalgia Patients. The FIMOUV 2 Study

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